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Beneficial Bacteria Treatment for Autism (BBT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02504554
Recruitment Status : Completed
First Posted : July 22, 2015
Results First Posted : December 18, 2019
Last Update Posted : December 18, 2019
Sponsor:
Collaborators:
Northern Arizona University
University of Arizona
University of Minnesota
Information provided by (Responsible Party):
Arizona State University

Study Description
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Brief Summary:

This is an open-label clinical trial to investigate a combination therapy for treating gastrointestinal problems in children with autism spectrum disorders.

The combination therapy includes beneficial bacteria.


Condition or disease Intervention/treatment Phase
Gastrointestinal Problems Autism Spectrum Disorders Drug: oral Vancomycin Drug: MoviPrep Drug: Prilosec Biological: human fecal material; processed, frozen administered orally Biological: human fecal material; processed, frozen; administered orally and rectally Phase 1 Phase 2

Detailed Description:

This is an open-label clinical trial to evaluate the safety, tolerability, and feasibility of a combination therapy to treat gastrointestinal problems in children with autism spectrum disorders.

It involves a combination therapy including beneficial bacteria.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating Gastrointestinal Problems in Children With Autism Using Beneficial Bacteria Treatment (BBT)
Study Start Date : July 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Oral Group
This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
 Drug: oral Vancomycin
an antibiotic

Drug: MoviPrep
a bowel cleanse

Drug: Prilosec
a stomach acid suppressan

Biological: human fecal material; processed, frozen administered orally
human fecal material; processed, frozen, administered orally
Experimental: Rectal Group
This group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
 Drug: oral Vancomycin
an antibiotic

Drug: MoviPrep
a bowel cleanse

Drug: Prilosec
a stomach acid suppressan

Biological: human fecal material; processed, frozen; administered orally and rectally
human fecal material; processed, frozen; administered orally and rectally


Outcome Measures
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Primary Outcome Measures :
  1. Gastrointestinal Symptom Responsiveness Scale (GSRS) [ Time Frame: Baseline and 10 weeks (end of treatment) ]
    The GSRS is a measure of gastrointestinal symptoms. It includes 15 questions, rated on a Likert scale of 1-7, from no symptoms to severe symptoms, respectively (i.e., higher is worse). We report an average score for all 15 questions, so the possible range for the average score is also 1-7.


Secondary Outcome Measures :
  1. Parent Global Impressions-Revised (PGI-R) [ Time Frame: Baseline and 10 weeks (end of treatment) ]
    The PGI-R is a rating of change of 18 autism symptoms compared to baseline, with each symptom rated on a Likert scale from -3 (much worse) to zero (no change) to +3 (much better). We report the average change of the 18 symptoms, so the possible range is from -3 to +3.

  2. Blood Safety Markers (Assessment of Blood Chemistry Panel and Complete Blood Count) [ Time Frame: Baseline and 10 weeks (end of treatment) ]
    Number of participants who had a clinically significant change in their blood safety markers (comprehensive metabolic panel including kidney/liver function and complete blood count with differential)

  3. Childhood Autism Rating Scale (CARS) [ Time Frame: Baseline and 10 weeks (end of treatment) ]
    The CARS is an assessment of 15 autism-related symptoms. Each item is scored on a scale of 1 (no symptoms) to 4 (severe symptoms), and the scores for each symptom are summed to obtain a total score. So, the possible scores range from 15 to 60, with a higher score indicating greater severity.

  4. Social Responsiveness Scale (SRS) [ Time Frame: Baseline and 10 weeks (end of treatment) ]
    The SRS is an assessment of social skills based on 65 items, where each item is scored on a range of 0 (no symptoms) to 3 (severe symptoms). The total score is a sum of the individual scores, so the total possible range is from 0 to 195, with a higher score indicating greater severity of symptoms.

  5. Short Sensory Profile [ Time Frame: baseline and 10 weeks ]

    The Short Sensory Profile is an assessment of sensory problems.

    However, the data on this scale was not collected due to administrative error.


  6. Vineland Adaptive Behavior Scale (VABS) [ Time Frame: baseline and 18 weeks (8 weeks after treatment stopped) ]
    The VABS is an assessment of adaptive behaviors, and we analyzed it to determine the developmental age of the participants, with possible scores ranging from 0 years to 21 years.

  7. Daily Stool Record (DSR) [ Time Frame: Baseline and 10 weeks (end of treatment) ]
    The DSR is a record of the type of stool that a participant had each day, using the Bristol Stool Form which ranges from 1 (very hard) to 7 (liquid). We then analyzed the data as % days of abnormal stools over a 14 day period, where an abnormal stool is defined as an unusually hard stool (types 1-2), unusually soft stool (types 6-7), or no stool that day. So, the possible range of % days of abnormal stools is from 0% to 100%, with a higher score indicating a more severe problem.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children ages 7-17 years
  2. Diagnosis of autism per Autism Diagnostic Interview-Revised (ADI-R)
  3. Moderate or Severe GI problems ( on the GSRS, a single score of 4 (severe) on any item, or a score of 3 (moderate) on two items, or a score of 2 (mild) or more on any 4 items
  4. No changes in medications, supplements, diet, therapies, or education in last 3 months, and no intention to change them during clinical trial
  5. General good physical health aside from gastrointestinal problems
  6. Cognitive Ability to Provide Informed Assent

Exclusion Criteria:

  1. Antibiotics in last 6 months
  2. Probiotics in last 3 months
  3. Single-gene disorder (Fragile X, etc.)
  4. Major brain malformation
  5. Tube feeding
  6. Severe gastrointestinal problems that require immediate treatment (life-threatening)
  7. Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic Gastroenteritis, or similar conditions
  8. Severely underweight/malnourished
  9. Recent or scheduled surgeries
  10. Current participation in other clinical trials
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504554


Sponsors and Collaborators
Arizona State University
Northern Arizona University
University of Arizona
University of Minnesota
Investigators
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Principal Investigator: James B Adams, PhD Arizona State University
More Information
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Publications of Results:

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Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT02504554    
Other Study ID Numbers: STUDY00001053
First Posted: July 22, 2015    Key Record Dates
Results First Posted: December 18, 2019
Last Update Posted: December 18, 2019
Last Verified: November 2019
Keywords provided by Arizona State University:
children
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Vancomycin
Omeprazole
 Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action